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Last Updated: December 22, 2024

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Drug Patent Profile


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Which patents cover Enalapril Maleate And Hydrochlorothiazide, and what generic alternatives are available?

Enalapril Maleate And Hydrochlorothiazide is a drug marketed by Chartwell Rx, Cosette, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Nostrum Labs Inc, Rising, and Taro Pharm Inds. and is included in seven NDAs.

The generic ingredient in ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Enalapril Maleate And Hydrochlorothiazide

A generic version of ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE was approved as enalapril maleate; hydrochlorothiazide by TARO PHARM INDS on September 18th, 2001.

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Summary for ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Drug patent expirations by year for ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Pharmacology for ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

US Patents and Regulatory Information for ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 076116-001 Sep 19, 2001 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ivax Sub Teva Pharms ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075736-001 Mar 25, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cosette ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075727-002 Sep 18, 2001 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075624-002 Sep 18, 2001 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ivax Sub Teva Pharms ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075736-002 Mar 25, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Taro Pharm Inds ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075788-002 Sep 18, 2001 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 076116-002 Sep 19, 2001 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Enalapril Maleate and Hydrochlorothiazide

Introduction to Enalapril Maleate and Hydrochlorothiazide

Enalapril maleate, an angiotensin-converting enzyme (ACE) inhibitor, and hydrochlorothiazide, a diuretic, are often combined to treat hypertension, congestive heart failure, and to prevent myocardial infarction. This combination therapy has become a cornerstone in cardiovascular treatment due to its efficacy and cost-effectiveness.

Market Size and Growth Projections

The global market for Enalapril Maleate is poised for significant growth. Here are some key projections:

  • Compound Annual Growth Rate (CAGR): The market is expected to grow at a CAGR of 6.20% from 2024 to 2031[2].
  • Revenue Projections: The market is anticipated to reach substantial revenue in USD million by 2031, driven by the increasing demand for effective cardiovascular treatments[2].

Historical and Forecast Periods

  • Historical Period: The market analysis spans from 2019 to 2023, with 2023 serving as the base year.
  • Forecast Period: The forecast period extends from 2024 to 2031, during which robust growth is expected due to various market drivers[2].

Key Drivers of Market Growth

Rising Prevalence of Cardiovascular Diseases

The increasing prevalence of hypertension, congestive heart failure, and other cardiovascular diseases is a primary driver of the Enalapril Maleate market. As populations age and lifestyle-related health issues rise, the demand for effective treatments like enalapril and hydrochlorothiazide is expected to surge[2].

Cost-Effectiveness

Enalapril therapy has been shown to be cost-effective, particularly in managing congestive heart failure. Studies indicate that enalapril can reduce healthcare costs by $170 to $250 over a four-year period due to reduced hospitalizations[3][2].

Expanding Healthcare Access

Improving healthcare infrastructure and access, especially in the Asia-Pacific region, is expected to boost market growth. As more people gain access to healthcare services, the demand for treatments like enalapril and hydrochlorothiazide is likely to increase[2].

Geographical Market Dynamics

North America

  • Currently dominates the Enalapril Maleate market, driven by the growing prevalence of high blood pressure and cardiovascular diseases.
  • Expected to continue significant growth during the projected period[2].

Asia-Pacific

  • Anticipated to experience the highest CAGR, driven by rising hypertension rates and improving healthcare access.
  • Growing awareness of cardiovascular health and a shift towards preventive care are key factors[2].

Europe

  • Expected to grow at a CAGR of 4.7% from 2024 to 2031.
  • Countries like the UK are showing a higher growth rate of 5.5%[2].

Latin America and Middle East & Africa

  • These regions, though smaller in market share, are also expected to grow, with CAGRs of 5.6% and 5.9%, respectively[2].

Market Opportunities

Growing Demand for Cardiovascular Treatments

The increasing incidence of cardiovascular diseases presents a significant opportunity for the growth of the Enalapril Maleate market. As more patients require treatment, the demand for enalapril and hydrochlorothiazide is expected to rise[2].

Expanding Healthcare Access

Improving healthcare infrastructure, especially in emerging markets, is expected to boost market growth by increasing access to these medications[2].

Market Challenges

Side Effects and Adverse Reactions

Enalapril can cause side effects such as hyperkalemia, dizziness, and kidney problems, which may deter some patients and affect market growth. The combination with hydrochlorothiazide can also lead to additional side effects like symptomatic hypotension and hyperesthesia of the oral mucosa[1][4].

Regulatory Hurdles

Strict regulatory environments and the need for continuous clinical trials to ensure safety and efficacy can pose challenges to market expansion. Regulatory approvals and compliance can be time-consuming and costly[2].

Financial Impact and Cost-Effectiveness

Cost Savings

Enalapril therapy has been shown to reduce healthcare costs by reducing hospitalizations. A study estimated that enalapril can save $170 to $250 over a four-year period for congestive heart failure patients[3][2].

Market Revenue

The global Enalapril Maleate market is projected to reach significant revenue in USD million by 2031, driven by its widespread use in treating hypertension and heart failure[2].

Combination Therapy: Enalapril Maleate and Hydrochlorothiazide

Efficacy

The combination of enalapril maleate and hydrochlorothiazide has been found to be highly effective in reducing blood pressure. Studies have shown that this combination results in a marked further reduction in blood pressure that is greater than the sum of the reductions from the individual drugs[1].

Clinical Use

This combination is indicated for the treatment of essential hypertension in patients for whom this combination therapy is appropriate. However, it is not recommended for initial therapy, and patients should be titrated on individual drugs before starting the combination[4].

Adverse Reactions

Common adverse reactions include fatigue, orthostatic effects, asthenia, chest pain, syncope, and hyperkalemia. Less common reactions can include elevations of liver enzymes and/or serum bilirubin, and a higher risk of skin cancers like squamous cell carcinoma and basal cell carcinoma with long-term use of hydrochlorothiazide[4].

Key Takeaways

  • Market Growth: The Enalapril Maleate market is expected to grow significantly due to the rising prevalence of cardiovascular diseases.
  • Cost-Effectiveness: Enalapril therapy is financially beneficial by reducing healthcare costs through reduced hospitalizations.
  • Geographical Dynamics: North America currently dominates the market, but the Asia-Pacific region is expected to grow at the highest CAGR.
  • Challenges: Side effects and regulatory hurdles are key challenges, but the market outlook remains positive.

FAQs

What is Enalapril Maleate used for?

Enalapril maleate is used to treat high blood pressure (hypertension), congestive heart failure, and to prevent myocardial infarction[2].

What are the key drivers of the Enalapril Maleate market?

The key drivers include the rising prevalence of cardiovascular diseases, cost-effectiveness, and expanding healthcare access[2].

Which regions dominate the Enalapril Maleate market?

North America currently dominates the market, but the Asia-Pacific region is expected to grow at the highest CAGR[2].

What are the potential side effects of Enalapril Maleate and Hydrochlorothiazide?

Common side effects include dizziness, hyperkalemia, and kidney problems. Less common side effects can include chest pain, cough, and fainting. The combination with hydrochlorothiazide can also lead to additional side effects like symptomatic hypotension and hyperesthesia of the oral mucosa[1][4].

How cost-effective is Enalapril Maleate therapy?

Enalapril therapy can reduce healthcare costs by $170 to $250 over a four-year period due to reduced hospitalizations for congestive heart failure patients[3][2].

Sources

  1. Comparative antihypertensive effects of enalapril maleate... - PubMed[1]
  2. Enalapril maleate - Generic Drug Details - DrugPatentWatch[2]
  3. A cost-effectiveness analysis of enalapril maleate in the... - PubMed[3]
  4. ENALAPRIL MALEATE /HCTZ - AA Pharma[4]

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